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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1299-5868 | Registry Identifier | WHO Universal Trial Number | |
| DRKS00033411 | Registry Identifier | German Clinical Trials Register |
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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
| AstraZeneca | INDUSTRY |
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The aim of this registry study with long-term follow-up is to record the course of therapy and disease in patients with recurrent and metastatic prostate cancer. The following patient groups are planned:
These four groups of patients are enrolled and observed independently of each other at different time periods.
This prospective real-world data and long-term follow-up registry study aims at documenting routine treatment and course of disease of patients with metastatic prostate cancer and patients with biochemical recurrence after local treatment. This may include the following patient cohorts:
Cohort 1: biochemical recurrence after local curative intended treatment (e.g. radical prostatectomy, radiotherapy of the prostate or combination thereof) Cohort 2: non-metastatic castration-resistant prostate cancer Cohort 3: metastatic hormone-sensitive prostate cancer Cohort 4: metastatic castration-resistant prostate cancer These cohorts will be recruited independently at various time frames. No specific study treatment is defined. All treatments are prescribed and performed according to each center's medical practice. Any treatment choice or change in regimen is performed at the discretion of each treating physician. During the routine visits, routine data on the course of the disease and therapy are documented for all cohorts at certain time points (after inclusion, then every 3 or 6 months and when changing therapy), standardized quality of life questionnaires (FACT-P and EQ-5D-5L) and biomaterial is collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: biochemical recurrence (BCR) after local curative intended treatment | |||
| Cohort 2: non-metastatic castration-resistant prostate cancer (nmCRPC) | |||
| Cohort 3: metastatic hormone-sensitive prostate cancer (mHSPC) | |||
| Cohort 4: metastatic castration-resistant prostate cancer (mCRCP) |
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| Measure | Description | Time Frame |
|---|---|---|
| Therapy Frequencies and Patterns of Therapy | Description of therapy frequencies and patterns in routine clinical practice for the included patient cohorts | Through study completion, an average of 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Annual (vs. cumulative) Patterns of Disease Management | Description of annual (vs. cumulative) patterns of disease management i.e. choice of treatment applied in German routine practice (including initial disease/ metastatic diagnosis and previous cancer drug and non-drug treatments) | Through study completion, an average of 7 years |
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Inclusion Criteria:
Exclusion Criteria:
• Patients who are not eligible for observation due to severe comorbidities or unavailability according to the treating physician
Presence of Prostate
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Adult prostate cancer patients (age ≥18 years) who will receive a new line of systemic therapy at the time of study entry or up to 4 weeks thereafter.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Rößler, PhD | Contact | 00491736872306 | andrea.roessler@urotrials.de | |
| Lisa Marx-Blümel, PhD | Contact | 004915202489234 | lisa.marx-bluemel@urotrials.de |
| Name | Affiliation | Role |
|---|---|---|
| Marc-Oliver Grimm, Professor | University Hospital Jena | Study Director |
| Boris Hadaschik, Professor | University Hospital, Essen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Freiburg | Recruiting | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
A Steering Committee is established for the study. SC will decide about requests for specific analyses. In case of positive opinion analyses will be done in-house and results provided to researchers.
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Exploratory molecular analyses of leucocyte DNA and RNA, circulating cell-free tumor DNA and RNA (plasma) as well as protein-biomakers (serum) in correlation with clinical outcomes
| Methodology for Disease Status Assessment |
Methodology used for disease status assessment (e.g. PSA-measurements, imaging) |
| Through study completion, an average of 7 years |
| Frequency for Disease Status Assessment | Frequency for disease status assessment (e.g. PSA-measurements, imaging) | Through study completion, an average of 7 years |
| Drug Effectiveness Depending on Prior Treatment | Assessment of drug effectiveness depending on prior use of an ARPI, docetaxel and other drugs in the BCR, nmCRPC and mHSPC setting as well as prior treatments for mCRPC | Through study completion, an average of 7 years |
| Parameters Affecting Prognosis | Identification of parameters affecting patients prognosis | Through study completion, an average of 7 years |
| Incidence of Adverse Events, serious Adverse Events | Incidence of AEs and sAEs including long term safety and tolerability | Through study completion, an average of 7 years |
| Treatment Adherence | Assessment of Treatment Adherence of patients undergoing different treatment regimes within the distinct cohorts | Through study completion, an average of 7 years |
| Assessment of Patient Reported Outcomes for cohort 1 | Including Patients Quality of Life affected by Treatment using EORTC QLQ-C30 (cohort 1) | Through study completion, an average of 7 years |
| Assessment of Patient Reported Outcomes for cohort 2-4 (EQ-5D-5L) | Including Patients Quality of Life affected by Treatment using EQ-5D-5L | Through study completion, an average of 7 years |
| Assessment of Patient Reported Outcomes for cohort 2-4 (FACT-P) | Including Quality of Life by Treatment using FACT-P | Through study completion, an average of 7 years |
| Assessment of Patient Paths I | Place of Initial and Metastatic Diagnosis, Involved Treatment Facilities, Tumor Board Decisions | Through study completion, an average of 7 years |
| Assessment of Patient Paths II | Type of Initial and Metastatic Diagnosis, Involved Treatment Facilities, Tumor Board Decisions | Through study completion, an average of 7 years |
| Applied Imaging Assessments II | PET/CT | Through study completion, an average of 7 years |
| Applied Imaging Assessments III | Bone scan | Through study completion, an average of 7 years |
| Applied Imaging Assessments IV | PSMA-SPECT/CT | Through study completion, an average of 7 years |
| Applied Imaging Assessments V | MRI | Through study completion, an average of 7 years |
| Applied Imaging Assessments VI | CT | Through study completion, an average of 7 years |
| Applied Imaging Assessments VII | PSMA PET/CT | Through study completion, an average of 7 years |
| Description of Patient and Tumor Characteristics | Including Molecular Alterations, if Assessed) in Routine Care of mHSPC and mCRPC Patients | Through study completion, an average of 7 years |
| National Center for Tumor Dieseases (NCT) Heidelberg | Recruiting | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
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| University Hospital Mannheim | Recruiting | Mannheim | Baden-Wurttemberg | 68167 | Germany |
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| Medical Office for Urology Nürtingen | Recruiting | Nürtingen | Baden-Wurttemberg | 72622 | Germany |
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| Studienpraxis Urologie | Recruiting | Nürtingen | Baden-Wurttemberg | 72622 | Germany |
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| University Hospital Tübingen | Recruiting | Tübingen | Baden-Wurttemberg | 72076 | Germany |
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| University Hospital Ulm | Recruiting | Ulm | Baden-Wurttemberg | 89081 | Germany |
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| University Hospital Augsburg | Recruiting | Augsburg | Bavaria | 86156 | Germany |
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| University Hospital Augsburg | Recruiting | Augsburg | Bavaria | 86156 | Germany |
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| Hospital Bayreuth GmbH | Recruiting | Bayreuth | Bavaria | 95445 | Germany |
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| University Hospital Erlangen | Recruiting | Erlangen | Bavaria | 91054 | Germany |
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| Hospital Kempten | Recruiting | Kempten (Allgäu) | Bavaria | 87439 | Germany |
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| Hospital Nürnberg North | Recruiting | Nuremberg | Bavaria | 90419 | Germany |
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| Caritas-Hospital St. Josef | Recruiting | Regensburg | Bavaria | 93053 | Germany |
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| University Hospital Würzburg | Recruiting | Würzburg | Bavaria | 97080 | Germany |
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| "Vivantes Prostatazentrum" Hospital "am Urban" | Recruiting | Berlin | Brandenburg | 10967 | Germany |
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| University Hospital Hamburg-Eppendorf | Recruiting | Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
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| University Hospital Frankfurt/Main | Recruiting | Frankfurt am Main | Hesse | 60590 | Germany |
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| Universitiy Hospital Gießen und Marburg GmbH, Site: Gießen | Recruiting | Giessen | Hesse | 35392 | Germany |
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| Universital Hospital Gießen & Marburg GmbH, Site: Marburg | Recruiting | Marburg | Hesse | 35043 | Germany |
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| Hospital Wetzlar | Recruiting | Wetzlar | Hesse | 35578 | Germany |
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| Medical Office for Urology | Recruiting | Braunschweig | Lower Saxony | 38100 | Germany |
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| Medical Office for Urology | Recruiting | Herzberg am Harz | Lower Saxony | 37412 | Germany |
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| St. Bernward Hospital Hildesheim | Recruiting | Hildesheim | Lower Saxony | 31134 | Germany |
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| St. Bernward Krankenhaus GmbH | Recruiting | Hildesheim | Lower Saxony | 31134 | Germany |
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| Medical Office for Urology Altstadtquartier Magdeburg | Recruiting | Magdeburg | Lower Saxony | 39104 | Germany |
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| MVZ Onco Medical GmbH Neustadt | Recruiting | Neustadt am Rübenberge | Lower Saxony | 31535 | Germany |
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| Praxisgemeinschaft f. Onkologie & Urologie | Recruiting | Wilhelmshaven | Lower Saxony | 26389 | Germany |
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| University Hospital Rostock | Recruiting | Rostock | Mecklenburg-Vorpommern | 18057 | Germany |
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| University Hospital Aachen | Recruiting | Aachen | North Rhine-Westphalia | 52074 | Germany |
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| Medical Office for Urology | Recruiting | Bayenthal | North Rhine-Westphalia | 50968 | Germany |
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| Marien Hospital Bergisch Gladbach, | Recruiting | Bergisch Gladbach | North Rhine-Westphalia | 51465 | Germany |
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| Johanniter GmbH, Johanniterkrankenhaus | Recruiting | Bonn | North Rhine-Westphalia | 53113 | Germany |
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| Johanniter Hosptal Bonn | Recruiting | Bonn | North Rhine-Westphalia | 53113 | Germany |
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| University Hospital Bonn | Recruiting | Bonn | North Rhine-Westphalia | 53127 | Germany |
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| Medical Office for Urology "Urologicum" | Recruiting | Duisburg | North Rhine-Westphalia | 47169 | Germany |
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| University Hospital Düsseldorf | Recruiting | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
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| University Hospital Essen | Recruiting | Essen | North Rhine-Westphalia | 45147 | Germany |
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| Marien Hospital Herne, University Hospital der Ruhr-Universität Bochum | Recruiting | Herne | North Rhine-Westphalia | 44625 | Germany |
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| "Brüder" Hospital St. Joseph Paderborn | Recruiting | Paderborn | North Rhine-Westphalia | 33098 | Germany |
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| University Hospital Wuppertal | Recruiting | Wuppertal | North Rhine-Westphalia | 42283 | Germany |
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| Medical Office for Urology | Recruiting | Würselen | North Rhine-Westphalia | 52146 | Germany |
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| Urban Hospital Karlsruhe | Recruiting | Karlsruhe | Rhineland-Palatinate | 76133 | Germany |
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| Hospital "Barmherzigen Brüder "Trier | Recruiting | Trier | Rhineland-Palatinate | 54292 | Germany |
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| Center for Urology Boxberg | Recruiting | Neunkirchen | Saarland | 66538 | Germany |
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| University Hospital Leipzig | Recruiting | Leipzig | Saxony | 04103 | Germany |
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| City Hospital Dessau | Recruiting | Dessau | Saxony-Anhalt | 06847 | Germany |
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| Universitiy Hospital Halle | Recruiting | Halle | Saxony-Anhalt | 06120 | Germany |
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| University Hospital Halle | Recruiting | Halle | Saxony-Anhalt | 06120 | Germany |
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| Urologie Altstadtquartier Magdeburg | Recruiting | Magdeburg | Saxony-Anhalt | 39104 | Germany |
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| University Hospital Magdeburg | Recruiting | Magdeburg | Saxony-Anhalt | 39120 | Germany |
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| Univerity Hospital Schleswig-Holstein | Recruiting | Lübeck | Schleswig-Holstein | 23562 | Germany |
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| University Hospital Jena | Recruiting | Jena | Thuringia | 07747 | Germany |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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